The Recall Desk
HighFDA (Devices)·Z-3139-2026·Announced 2026-09-30

CooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk

CooperSurgical is recalling specific lots of INCA Infant Nasal CPAP tubing because a loose connection may cause loss of pressure and reduced oxygenation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device for infants where a defect could lead to decreased oxygenation, representing a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

CooperSurgical, Inc. is recalling 2,643 boxes (13,215 units) of INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set, specifically the Stay-Flex tubing component. The affected model numbers are 44-2707, 44-2709, 44-2710, 44-2712, and 44-2715. The recall covers specific lot codes and UDI-DIs listed in the agency's structured data.

The recall was initiated because the flexible tubing may exhibit a loose connection with the nasal cannula during assembly or use. This defect may result in a loss of CPAP pressure, which can reduce the effectiveness of treatment and lead to decreased oxygenation until the connection is restored.

The products were distributed nationwide to Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, Michigan, Mississippi, New Jersey, New York, Ohio, Pennsylvania, and Virginia, as well as internationally to Brazil and Peru. Consumers and healthcare providers should check their inventory against the specific model numbers and lot codes provided by the FDA and contact CooperSurgical for instructions on how to return the affected units.

The recalled product

Product
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Respiratory Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 550033781
  • 550031616
  • 550031620
  • 550031614
  • 550033779
  • 550033780
  • 550034763.

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Related recalls

Same manufacturer · CooperSurgical, Inc.

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Same hazard · loss of pressure

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